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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 66048
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
DMLC IV-ERGO - Beam shaping block for Radiation Therapy. EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046 Class II Clinical mistreatment may occur when there are errors in the clinical work flow. 31 Z-2157-2013